United States: The President's Precision Medicine Initiative – The First Annual Check-Up

Watching President Obama's recent 2016 State of the Union Address reminded me that one year has passed since the President announced a new "precision" or personalized medicine initiative to advance personalized, effective therapies for the American public. It was during his 2015 State of the Union Address that the President stated:1

"[T]onight, I'm launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthier. We can do this."

Soon after the President's address, details emerged regarding the Precision Medicine Initiative ("PMI"). $215 million was committed from the President's 2016 budget to be broadly allocated to National Institutes of Health ("NIH"), the Food and Drug Administration ("FDA") and the Office of the National Coordinator for Health Information Technology ("ONC"). The money was to be invested as follows:2

  • $130 million to NIH for the development of a voluntary national research cohort of a million or more volunteers who will voluntarily share health, familial and genetic information to be shared among responsible researchers;
  • $70 million to the National Cancer Institute (NCI), part of NIH, to understand the genetic drivers of cancer and improve therapies;
  • $10 million to FDA to modernize the regulatory structure and process to advance precision medicine;
  • $5 million to ONC for the development of interoperability standards and requirements that support PMI.

The money was to be invested to support PMI's stated objectives of:3

  • More and better treatments for cancer;
  • Creation of a voluntary national research cohort;
  • Commitment to protecting privacy;
  • Regulatory modernization; and
  • Public-private partnerships.

NIH's Voluntary Research Cohort

In March of 2015, a PMI Working Group ("Group") was organized by NIH to develop a framework for the volunteer cohort program. As an initial matter, the group was challenged to develop a framework for "creating and managing the voluntary research cohort to understand the variables that contribute to health and disease."4 The Group's report (The Precision Medicine's Initiative Cohort Program – Building a Research Program for 21st Century Medicine, "Report" available here) was published in September of 2015 with the following recommendations:

  • Cohort Assembly. The Group supported the initial goal to include one million diverse volunteers with the number of volunteers to increase over time. The volunteers should be required to share their health data, provide a biospecimen, and be available for future research. Two approaches were recommended for the recruitment of volunteers. First, any individual living in America may volunteer provided they consent to undertake a baseline health exam and provide a biospecimen. They also would be required to share available health data by either directing their electronic health record (EHR) data to the researchers and/or by undergoing an initial exam with a health care provider. Volunteers also must consent to be contacted for follow up. The second recommended approach would recruit volunteers by collaborating with healthcare provider organizations (HPOs).
  • Participant Engagement. The Group recommended that the volunteer cohort be developed and allowed to contribute in all aspects of the cohort. Participants are recommended to have significant representation on governance and oversight committees. To ensure that participant-related interactions remain consistent throughout the cohort study, the Group recommended that activities related to engagement and communications be organized and managed by a central entity. Volunteers should get their individual results as well as information from the cohort aggregate. Volunteers also should be free to set preferences to dictate how much personal information they receive, and to be able to change their preferences throughout their participation in the study.
  • Data Considerations. A combination of well-proven and innovative methods and technologies for data collection and management is noted by the Group to be necessary for successful development of the cohort program. To that end, the Working Group recommends that the initial core data set acquired from all cohort participants be collected and stored centrally and that this initial data set be aligned comparable core data sets where possible. The recommended initial core data set includes data from electronic health records, health insurance organizations, participant surveys, mHealth technologies, and biologic investigations, and would be expected to grow with time. Report at page 3. Existing data standards and common data models are recommended to be used where possible to normalize information from various platforms.
  • Security. Data access control is recommended to ensure that the collected data is used responsibly and securely. Access will depend on the sensitivity of the data, from open-access to role-based access for more sensitive information. Report at page 4. Participants should have access to their own data where appropriate, but access could be denied if there are compelling concerns about potential harm that may arise from such access.
  • Biospecimens. The collection and use of biological specimens is considered essential to the successful development of the cohort program. While there are many different types of tissue that could be collected, a new blood specimen is recommended as the initial specimen. The biological specimens should be sent to central biorepository, "which will support collection, processing, storage, retrieval and biochemical analysis and/or shipment to analytic laboratories." Report at page 5.
  • Policy considerations. The Report noted that the success and longevity of the cohort program would be influenced by the "laws, regulations, and policies surrounding research, data security and privacy, and access and interoperability" electronic health records" Report at page 4. One notable recommendation of the Group is the use of a single IRB to reduce administrative burden and associated costs of the cohort, review time, and to harmonize inconsistent or conflicting policies between different patient groups.
  • Governance. The Group recommended that a director be appointed to lead the patient group. The director should "have authority to set short and long-term goals, develop solicitations and make award recommendations, and have authority over data sharing, storage, and use. Report at page 5. Also recommended is the creation of a Steering Committee of critical stakeholders led by a smaller Executive Committee and five subcommittees that would report to and the director. An Independent Advisory Board should also be created to provide external oversight for the patient cohort group.

NCI and Genetic Research

In August of 2015, the National Cancer Institute announced that it was focusing its PMI activities in for broad areas:5

  • Expanding Precision Medicine Clinical Trials. NCI announced that in partnership with both the public and private sectors, several precision medicine trials were initiated. An example of such is a clinical trial initiative that seeks to match patients with clinical trials, based on the genetic abnormalities in a patient's tumors, regardless of the type of cancer they have.
  • Overcoming Drug Resistance. NCI is increasing its support of research to address treatment resistance. This initiative is reported to involve:

    • Using tumor profiling to better understand treatment resistance; and
    • Establishing a repository of laboratory models derived from patient tumor samples to investigate drug resistance.
  • Developing New Laboratory Models for Research. NCI will increase its efforts to develop new laboratory models of human cancer.
  • Developing a National Cancer Knowledge System. NCI reported that a national database would be established to house and integrate genomic information from tumors with clinical response data (e.g., tumor shrinkage) and outcomes information (e.g., length of survival) as a resource for scientists, health care professionals, and patients.6

Health Information Technology

In September of 2015, the Health Information Technology Standards Committee (HITSC) provided their recommendations to support of PMI. The group's recommendations, outlined in their reporting letter, fell into four categories:

  • Readily Applicable Standards for PMI – defined as standards that have been tested and implemented in the health IT market that can be put to use to support the NIH PMI cohort and precision medicine.
  • Promising Standards for PMI – defined as standards that may require additional effort, including further pilots and testing, to support precision medicine.
  • Standards Gaps for PMI – defined as areas where considerable additional standards development work is needed.
  • Accelerators – identified as opportunities to advance and improve the standards that fell in the previous categories.

Food and Drug Administration

In December of 2015, FDA announced the launch of an online, cloud-based, portal that will allow interested stakeholders to collaborate and develop the applications of next-generation sequencing. As explained by FDA's blog,

"The precisionFDA platform is a part of this larger effort and through its use we want to help scientists work toward the most accurate and meaningful discoveries. precisionFDA users will have access to a number of important tools to help them do this. These tools include reference genomes, such as "Genome in the Bottle," a reference sample of DNA for validating human genome sequences developed by the National Institute of Standards and Technology. Users will also be able to compare their results to previously validated reference results as well as share their results with other users, track changes and obtain feedback."

One Year Later — Much Done, Much More to Accomplish

In just one year, much has been accomplished to move the President's initiative forward.

An extensive framework has been created and associated funding and other support is being provided. We are at an exciting time for personalized medicine.


1. Remarks by the President in State of the Union Address, January 20, 2015, released by the White House Office of Press Secretary, available at https://www.whitehouse.gov/the-press-office/2015/01/20/remarks-president-state-union-address-january-20-2015.

2. The Fact Sheet: President Obama's Precision Medicine Initiative, released by the White House Office of Press Secretary, January 30, 2015, available at https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative.

3. Id.

4. https://www.nih.gov/precision-medicine-initiative-cohort-program/pmi-working-group.

5. NCI and the Precision Medicine Initiative, available at http://www.cancer.gov/research/key-initiatives/precision-medicine.

6. Id.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.